• Following approval by the European Commission (EC), sugemalimab has received a new indication approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for stage III non-small cell lung cancer (NSCLC). This marks the second indication approved for the product in the UK.
• This approval is based on the GEMSTONE-301 study, a multicenter, randomized, double-blind Phase III trial. Results demonstrated that sugemalimab provided statistically significant improvement in progression-free survival (PFS) and a clinically meaningful prolongation of overall survival (OS) in patients with stage III NSCLC.
• To date, CStone has established four commercialization partnerships for sugemalimab across Europe, the Middle East and Africa, and Latin America, extending its reach to more than 60 countries and regions. The global commercial rollout is now actively underway.

CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas,announced that the UK MHRA has granted a new indication for sugemalimab as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy (CRT).

Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated, "Since its initial EU approval in July 2024, sugemalimab has become one of only two PD-(L)1 antibodies approved for stage III NSCLC in Europe, providing a comprehensive treatment option spanning both locally advanced, unresectable stage III and metastatic stage IV NSCLC. Its commercial footprint has now expanded to over 60 countries and regions globally, with market access applications approved or under regulatory review in more than ten countries. Furthermore, sugemalimab has been included in multiple national reimbursement systems—an affirmation of its recognized clinical value and pharmacoeconomic benefit."

Dr. Qingmei Shi, Chief Medical Officer of CStone, added, "The MHRA's approval of sugemalimab for Stage III NSCLC represents another significant endorsement from a major international regulatory agency and will further unlock its global commercial potential. We are proud of CStone's clinical development and regulatory affairs teams for their' effective execution, invaluable experience in global registration, and ability to navigate mature regulatory frameworks in Europe and the UK. Sugemalimab in combination with chemotherapy treating stage IV NSCLC has received the highest-level recommendation [I, A] in the first-line setting for both squamous and non-squamous NSCLC in the European Society for Medical Oncology (ESMO) Non-Oncogene-Addicted Metastatic NSCLC Living Guideline. We look forward to the potential inclusion of this newly approved stage III NSCLC indication in this authoritative guideline in the near future. CStone will continue to advance regulatory filings for sugemalimab in additional indications, including gastric cancer (GC) and esophageal squamous cell carcinoma (ESCC)."